Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis
LISLA
Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA
1 other identifier
interventional
23
1 country
1
Brief Summary
The purpose of the study is to determine whether lithium is safe and effective in the treatment of ALS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedOctober 31, 2012
March 1, 2009
1.8 years
June 19, 2009
October 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone )
15 months
Secondary Outcomes (3)
Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope)
15 months
Muscle Strength Change in MMT score (MMT slope)
15 months
Rate of decline of respiratory function determined as SVC over the 15 month treatment period
15 months
Study Arms (1)
1
EXPERIMENTALInterventions
lithium LP 400mg daily po (doses were adjusted during the study to maintain targeted blood levels.)
Eligibility Criteria
You may qualify if:
- Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the AIRLIE House Conference 1998)
- Concomitant standard Riluzole therapy (50mg twice daily)
- patients included in ALS reference center
- women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test
- capable of thoroughly understanding all information given and giving full informed consent according to GCP
- Patients with gastrostomy
You may not qualify if:
- evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
- any medical condition known to contre-indicate lithium treatment (dysthyroid, cardiopathy, renal insufficiency)
- presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
- known hypersensitivity to any component of the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pitié-Salpêtrière Hospital
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucette Lacomblez, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 22, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
October 31, 2012
Record last verified: 2009-03